Policyholder Services

Coverage of ROP IVAV Treatment

KIMBERLY WYNKOOP, OMIC Senior Legal Counsel, and BETSY KELLEY, Vice President, Product Development

OMIC’s focus on insuring only ophthalmology allows—and requires—us to thoroughly understand what ophthalmologists do. The ophthalmologists who started OMIC in 1987 wanted to ensure that their colleagues did not subsidize higher-risk specialties by paying unnecessarily high premiums. They also wanted to found a company that was robust enough to stay in business long-term yet flexible enough to change with their specialty.

From the beginning, OMIC’s Board and committee members and staff have paid particular attention to claims data to determine how to minimize liability exposure for our policyholders and to enhance safety for the patients these policyholders treat. At times, we have established conditions of coverage for specific types of care in response to an increase in the number of claims or the amount of money needed to settle them. Just as importantly, we have relaxed or eliminated certain requirements in response to feedback from our insureds and when claims data indicated the higher risk had passed. Earlier this year, for example, we removed extraocular refractive surgery from the list of procedures with conditions of coverage. Requirements for refractive surgery continue now only for intraocular surgery, such as refractive lens exchange and phakic implants.

Ophthalmologists who provide care to premature infants are at high risk, so we regularly review our conditions of coverage for ROP. Our ROP Task Force recently discussed several articles about intravitreal
anti-VEGF (IVAV) injections as primary or salvage therapy for ROP. When OMIC first developed its underwriting procedures for evaluating coverage of IVAV treatment, there was no published, peer-reviewed data to support a particular position. Therefore, OMIC asked general questions, such as “Under what circumstances do you administer IVAV?” “How long do you monitor patients for recurrence of ROP after IVAV?” and “What is the follow-up interval?”

In 2013, the American Academy of Pediatrics Section on Ophthalmology (AAP SOO) revised the “Screening Examination of Premature Infants for Retinopathy” and included guidelines for use of bevacizumab (Avastin) in the treatment of ROP. In this revised policy statement, the AAP SOO advises that infants
treated with bevacizumab should be monitored weekly after injection and that all infants treated for ROP solely with bevacizumab should be followed until full vascularization in close proximity to the ora serrata for 360° occurs. OMIC adopted these recommendations as underwriting requirements in May 2013.

Risk management and underwriting staff have since fielded questions and concerns regarding these follow-up criteria. Weekly exams become increasingly difficult as the infant ages and are not without stress for the infant, parent, and ophthalmologist alike. In addition, some infants’ eyes do not fully vascularize. While in some cases the physician may elect to perform laser surgery to prevent recurrence, our policyholders did not feel that all infants warrant such treatment. The physicians who contacted OMIC felt that our requirements were not always consistent with their best professional judgment or in the infant’s best interest. Accordingly, they requested that OMIC reconsider them.

OMIC’s Task Force noted that guidelines for treatment of ROP are evolving. Many questions are currently
being studied and debated about IVAV. These issues include agent, dosage amount, volume, timing of
injections, length of follow-up, and contraindications. There is not yet enough data to develop consensus
recommendations. Because of the lack of published, peer-reviewed data regarding follow-up intervals and follow-up endpoints for infants treated for ROP with IVAV, the task force sought input from ROP thought leaders before making a determination. After reviewing the input, the task force concluded that OMIC should retain its current requirement to monitor infants weekly after injection but agreed that changes to the follow-up endpoint were warranted.

The OMIC Board adopted the following revised requirements in May 2016. Infants treated for ROP with IVAV must be followed until 1) full vascularization in close proximity to the ora serrata to 360° occurs or 2) the avascular retina has been successfully treated with laser (e.g., no skip areas). Ophthalmologists may use their professional judgment on continued monitoring in the following circumstances if no treatment endpoint has been reached three months after the injection: 1) lowgrade disease that is clearly and slowly improving, 2) stage 1 disease that is unchanged for two months, 3) no disease, no ROP, but incomplete vascularization, and 4) infants with DNR (do not resuscitate) orders.

We are updating the renewal ROP questionnaire to reflect these changes. Although you may receive a questionnaire that reflects the former requirements, the new, broader guidelines are already in effect. Ophthalmologists who treat ROP with anti-VEGF injections need to remain extremely vigilant. OMIC provides guidance in “Anti-VEGF Intravitreal Injections for ROP: Risk Management Analysis and Recommendations.” It is available online at http:/www.omic.com/rop-intravitrealanti-vegf-injections-risk-managementrecommendations/.